Severe and sometimes fatal liver problems have occurred with the use of Valproate Syrup. The risk is greater in children younger than 2 years old, especially those who have metabolic disorders, seizure disorders with mental retardation, brain disease, or who take multiple seizure medicines.
When liver problems have occurred, it usually has been during the first 6 months of treatment. Contact your doctor right away if symptoms of liver problems occur (eg, dark urine, general feeling of being unwell, loss of appetite, sluggishness, swelling of the face, vomiting, weakness, yellowing of the skin or eyes). Patients with seizure disorders may also experience worsening of seizures. Contact your doctor right away if this occurs. Liver function tests should be performed before you start Valproate Syrup and during treatment. Be sure to keep all doctor and lab appointments.
Valproate Syrup may cause severe birth defects if you take it while you are pregnant. Women who are able to become pregnant should discuss with their doctor the benefits and risks of using Valproate Syrup during pregnancy. Contact your doctor right away if you think you may be pregnant. An extra patient leaflet about this risk is available with Valproate Syrup. Read it carefully. Talk with your doctor if you have questions about this information.
Severe and sometimes fatal pancreas problems have occurred with the use of Valproate Syrup. These problems have occurred soon after starting Valproate Syrup, as well as after several years of treatment. Tell your doctor right away if you develop loss of appetite, nausea, stomach pain, or vomiting.
Treating certain seizure disorders. It may also be used for other conditions as determined by your doctor.
Valproate Syrup is an anticonvulsant. It works by increasing the amount of a certain chemical in the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Valproate Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Valproate Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Valproate Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Valproate Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Valproate Syrup.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; headache; increased or decreased appetite; mild hair loss; nausea; sore throat; stomach pain or upset; trouble sleeping; vomiting; weight gain.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavior changes; blurred vision or other vision changes; change in menstrual period; change in the amount of urine produced; chest pain; confusion; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; general feeling of being unwell; hallucinations; hearing loss; joint or muscle pain or weakness; loss of coordination; memory loss; mental or mood changes (eg, depression, nervousness); pale stools; red, swollen, or blistered skin; ringing in the ears; severe or persistent nausea, vomiting, or loss of appetite; severe or persistent stomach pain or cramps; sluggishness; suicidal thoughts or actions; swelling of the arms or legs; swollen lymph nodes; tremor; trouble speaking or walking; uncontrolled muscle movements; unusual bleeding or bruising; unusual tiredness or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include irregular heartbeat; loss of consciousness; or severe drowsiness.Proper storage of Valproate Syrup:
Store Valproate Syrup at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Valproate Syrup out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Valproate Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.